Mike Loveless

How to Improve Emotional Interaction With a Medical Device

Emotional Interaction Medical DevicesVisual rhetoric and emotional interaction in Medical Devices
Frequently in the medical device industry, the tangible importance of the aesthetic design of an object can be downplayed. It can be considered dressing or fluff and not important in the development of the device. However, aesthetic personality, visual rhetoric or emotional interaction with a medical device influence the experience that an operator and a patient have with the device.

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Dhruvitha Krishna

Variations Between FDA and EU MDR Requirements for Clinical Investigations

Clinical Investigations EU MDR FDA
Clinical investigations are defined within both FDA and EU MDR as the systematic investigation involving one or more human subjects, undertaken to collect data and assess the safety or performance of a device. Using the clinical data to demonstrate that the device meets the safety and effectiveness considerations is an important step in the device lifecycle.
Here, we will look at some of the differences between FDA and EU MDR process and requirements for clinical investigations.

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Vinky Kohli

Qualifying Medical Device Development Tools (MDDT)

Qualifying Medical Device Development Tools (MDDT)The US Food and Drug Administration (FDA)’s voluntary Qualification of Medical Device Development Tools (fda.gov) is intended to encourage use of innovative technologies and novel approaches to medical device development and create a favourable regulatory framework to expand the availability of entirely new medical devices to patients.
This blog includes an overview of MDDT program, its categories, history, benefits, Centre for Devices and Radiological Health (CDRH) Qualification Process and Decision Framework.

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Astero StarFish

5 Tips on Preparing for a Successful FDA Inspection

Tips Preparing FDA InspectionAs you gear up to face your impending FDA inspection, we’re here to lend a helping hand with five crucial tips for a smooth and successful FDA inspection.
Navigating the intricacies of regulatory compliance can be daunting, but fear not! Our expert advice will guide you through this difficult process, so your organization is well prepared to meet the FDA’s requirements.

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Helen Simons

Optimizing QA/RA Value in Medical Device Development

QA/RA Value Medical Device DevelopmentWhen thinking about the roles of Quality Assurance (QA) and Regulatory Affairs (RA), I like to use the metaphor of the trail blazer and the guide, RA is there to blaze the trail and find the path, QA is there to keep the team on that path and away from pitfalls and hazards.
RA does this by monitoring and reviewing the regulatory landscape, understanding the applicable laws and regulations, but also knowing about recent decisions by regulatory bodies and how interpretations of these directives and guidances can vary. QA keeps projects on track by being fully engaged in the Quality Management System (QMS) and knowing what needs to be done to ensure that the project is successful as well as compliant.

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Astero StarFish

Medical Device Phase One Product Development Pro Tips

Medical Device Product Development TipsOur employee experts share their best tips and examples for each phase of the commercialization process in a four-part series on Medical Device Commercialization. This blog covers Medical Device Phase One Product Development engineering, design and development. For Phase Zero tips, check out our blog on Product Definition.
Medical device commercialization is typically broken into Four Phases: Phase Zero Product Definition, Phase One Engineering Design and Development, Phase Two Transfer, and Phase Three Manufacturing.

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Paul Hulme

Look Before you Lead: Planning for Summative / Human Factors Validation Testing

Human Factors Validation PlanningHuman factors validation testing is the final usability testing to be completed prior to regulatory submission. A mistake or an omission may result in follow-up testing being required if you uncover unanticipated use errors during testing. Careful planning is highly recommended.
The following aspects should be considered for human factors validation planning. Each topic could be a chapter unto itself but for now we will keep it succinct.

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Rodolfo Prata

Patient-Centered Design

Patient-Centered DesignPatient-centered design is designing healthcare with the patient in mind, a methodology that prioritizes the patient’s desires and requirements. This encompasses constructing medical facilities, procedures, and systems to enhance patient care. The concept of patient-centered has gained considerable traction in recent years as healthcare organizations worldwide strive to improve their quality of care.
In this blog post, I will delve into the principles of patient-centered design advantages for patients and healthcare providers.

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Sunghyun Lee

What is Pantone and how can I use it in Medical Device Development?

Color plays an important role in a product. It can define a brand identity and help usability of a product. When it comes to medical devices, the role of color becomes even more critical, guided by safety standards and regulatory requirements.

When we are describing color, we merely state them as “white”, “red”, “gray”, etc. However, when it comes to defining color of a product, it needs more accuracy since these words cover a wide range of shades with varying levels of brightness (saturation) and color quality (hue).

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